Pulmonary Medicine Clinical Research

In addition to providing outstanding clinical care, members of the Section of Pulmonary Medicine conduct research and lead clinical trials to improve patient outcomes, especially in asthma and cystic fibrosis.

Clinical researchers at Nationwide Children's are committed to identifying new approaches for the prevention, diagnosis and treatment of childhood diseases, taking research discoveries from the lab to the patient's bedside.

Asthma Clinical Trials

Clinical researchers at Nationwide Children's are committed to identifying new approaches for the prevention, diagnosis and treatment of asthma, taking research discoveries from the lab to the patient's bedside.

Overview: Asthma-Related Clinical Trials at Nationwide Children's

Scientists have made observations suggesting that diets rich in soy-based proteins provide some protection for individuals with asthma. SOYA, as the study is named, focuses on difficult to control asthma comparing an oral soy supplement to placebo. Monitoring includes lung function, asthma control day count and quality of life. Our focus as the pediatric site for Asthma Clinical Research Center, ALA supported grant OSU-based study are those aged 12 and older.

We are examining the effect of using nasal steroids on asthma symptoms in a project titled the Study of Asthma and Nasal Steroids (STAN) is also supported by Asthma Clinical Research Center, ALA supported grant. Like SOYA, we are the pediatric site for an OSU-based grant. Patients with difficult to control asthma will be recruited and treated with either nasal steroids or placebo to determine if nasal steroids can significantly stabilize asthma symptoms. Our target population is 6 years and older.

Participants in STAN and SOYA are also recruited to participate in a large database to determine if certain biomarkers are related to a better response to asthma treatments. This type of knowledge helps us to select the best medical treatments for individual asthma patients and avoid less effective medical strategies.

In general, it is difficult to improve asthma care as new interventions come available and as guidelines change. This is particularly true among private practitioners. In a program that spanned about three years, we approached private practices to allow us to supply an on-site asthma coordinator. This effort was intended to improve asthma-related education among primary care colleagues. During this program we had "active" (intervention) and "placebo" (observation) practices. Midway through the program, the active and placebo practices crossed over. We saw major improvements during the time the coordinator was there and for six months after the study period, in both groups. These results were presented this fall at the European Respiratory Society in Amsterdam and a publication is now in preparation for submission.

Several years ago, an unfortunate asthma-related death occurred in a young African American athlete in Columbus, OH. As a result of this death, the community asked for a pre-season asthma screening. A team screened nearly 1,300 youth. Alarmingly, 45 to 50 percent of these youth screened positively for asthma. We know that hospitalizations and deaths among African Americans are significantly higher, but the prevalence of asthma in children is usually estimated at 9 to 10 percent.

When we reviewed these alarming results, it was not clear if this was a fluke or related to social economic factors. To follow up, Nationwide Children's pulmonologist Dr. Shahid Sheikh approached a suburban private school and an urban church, all exclusively African American. The rate of positives among the children based upon questionnaire and pulmonary function testing was again about 50 percent in both settings.

These findings indicate that even closer scrutiny for African American children is indicated and that every effort should be made to eliminate barriers to health care and improve education regarding symptoms, risks and treatments.

Cystic Fibrosis Clinical Trials

Clinical researchers at Nationwide Children's are committed to identifying new approaches for the prevention, diagnosis and treatment of cystic fibrosis, taking research discoveries from the lab to the patient's bedside.

We are participating in a multi-center study examining the psychosocial aspects of living with a chronic disease such as cystic fibrosis. When adolescents ignore their disease, they are more likely to see rapid advancement of pulmonary damage, which may lead to a shortening of life. Adolescence is a pivotal time in cystic fibrosis. This project aims to determine what psychosocial factors influence patients' desire and ability to keep up with recommended care and recognize and acknowledge symptoms as a way of helping them make healthy choices.

Since pulmonary infections and their related inflammation are the major cause of complications and premature death in cystic fibrosis, we are examining the effectiveness of medications (especially antibiotics) with novel delivery systems being developed for control of pulmonary infections.

We are examining the efficacy and tolerance of medications being developed to help remove the thickened secretions from the cystic fibrosis airway. This study is being conducted in infants, which is rare, but offers the promise of intervention at an earlier age with far-reaching potential benefits.

We are examining the safetey and effectiveness of mediations which target the primary defect in cells of cystic fibrosis patients. At present, these agents are directed at defects due to specific genes (there are more than 2,000). These agents may be able to help cystic fibrosis cells function like non-cystic fibrosis airway cells do. These are among the first candidate mediccations targeting the primary defect in cystic fibrosis.

Our doctors are examining exercise capabilities in cystic fibrosis patients to help identify tests/strategies that could help detect when patinet are in the early stages of respiratory compromise, before more obvious dangerous and life-threatening symptoms appear.

Along with national partners, we are working to determine appropriate endpoints for studies in cystic fibrosis patients. This is incredibly important because it will be how we evaluate the many new potential therapies. This is a major issue, since the advances in overall therapies have led to slowed progression of disease. We are working to determine more appropriate measures such as quality of life and/or CT scans, early life lung functions, days of more versus less symptoms. We may find that clinically undetectable changes in biologic markers are more informative.

We are examining ways to monitor and control and perhaps change the course of the unusual diabetes seen in adolescents and adults with cystic fibrosis. Using a new therapy for diabetes not previously explored in cystic fibrosis, we hope to see benefits that delay the onset of overt diabetes and control the sugar fluctuations seen in diabetes in a less invasive way.